化妆品输入美国FDA监督查询.doc

Import Surveillance (進口監督)進入美國FDA 網站 /default.htm點選上方Cosmetics 尋找右側Issues and Alerts 問題和警告點選 Import Surveillance 進口監督Import Surveillance進口監督The following are resources on FDAs surveillance and enforcement activities related to imported cosmetics: 以下是相關化妝品進口在FDA的監督和執法活動的資源： Import Alerts Related to Cosmetics 相關化妝品的進口警告An Import Alert allows FDA to detain, without physically examining, products that either have or potentially could violate the Federal Food, Drug, and Cosmetic Act.一個進口警告允許美國FDA扣留，無物理性檢查，這產品可能或已經違反美國聯邦食品，藥品和化妝品法。 Import Refusals Related to Cosmetics 拒絕進口相關化妝品Cosmetics offered for import that do not appear tocomply with U.S. law may berefused entry intothis country. The list ofImport Refusals is updated monthly.提供化粧品不能顯現出符合美國法律的進口化妝品可能被拒絕進入這個國家。而拒絕進口名單每月更新。 Cosmetics Compliance Program:Import and Domestic (PDF 310 KB)March 15, 2010 化妝品的合規性計劃：進口和國產 2010年3月15日 For information on some ongoing FDA compliance priorities related to cosmetics有關化妝品部分正在進行FDA認證的優先事項信息The following resources provide more information on FDAs import surveillance activities:以下資源提供有關FDA的進口監督活動的詳細信息： Federal Agencies Issue Draft Guidance for Industry Good Importer Practices January 12, 2009聯邦機構發布行業指南優良進口商草案規範2009年1月12日Import Program System Information進口程序系統信息An overview of FDA activities related to importsFDA的活動，涉及到進口的概述Regulatory Procedures Manual: Chapter 9 Import Operations/Actions 監督管理程序手冊：第9章 進口操作/行動For FDA procedures on import detentions, refusals, and moreFDA的進口扣留程序、拒絕和更多FDAs Office of Regulatory Affairs Imports Start Page FDA監督管理事務的進口開始頁For links to additional resources對於其他資源的鏈接Related Resources: 相關資源：Information forCosmetic Importers化妝品進口商信息Information for Cosmetic Exporters化妝品出口商信息International Trade Resources國際貿易資源點選 Import Refusals Related to Cosmetics 拒絕進口相關化妝品Import Refusals: Cosmetics 拒絕進口：化妝品If a cosmetic offered for import does not appear to be in compliance with U.S. law, it may be refusedentry into this country.如果提供進口化妝品沒有出現在遵守美國法律，有可能被拒絕進入這個國家。The following list of Import Refusals related to cosmetics during the last year is updated monthly.以下列表是去年每月更新拒絕進口的化妝品過程。For a complete inventory of Import Refusals affecting all FDA-regulated products, see Import Refusals. 對於拒絕進口影響所有FDA監管的產品的完整清單，請參閱Import RefusalsFor a list of Import Alerts related to cosmetics, see Import Alerts - Industry: Cosmetics. 對於相關化妝品進口警告的列表，請參閱 Import Alerts - Industry: Cosmetics.Import Refusals for CosmeticsAugust 2014July 2014June 2014May 2014April 2014March 2014February 2014January 2014December 2013November 2013October 2013September 2013 Related ResourcesCosmetics & U.S. LawFDA Authority Over CosmeticsIs It a Cosmetic, a Drug, or Both? (Or Is It Soap?)Key Legal Concepts: Interstate Commerce, Adulterated, and Misbranded Information for Cosmetic Exporters: FAQsInformation for Cosmetics ImportersImport Alerts for Cosmetics逐月點選 Import Refusals for Cosmetics 的月份Import Refusal ReportRefusal Actions by FDA as Recorded in OASISfor 53-CosmeticsEntry/doc/line/sfxRefusal DateProductCodeManufacturerFEIManufacturerNameManufacturerCountry/Area先行檢視 Manufacturer Country/Area , 找尋 China找到 China 後, 再找尋Manufacturer Name, 查xxxx Cosmetic Co 查到xxxx Cosmetic Co 點選該列之 Entry/doc/line/sfx April 2014 xxx-xxxxxxx-x/x/x 01-Apr-2014*CH*Xxxx Cosmetic Coxxx-xxxxxxx-x/x/x xxx-xxxxxxx-x/x/x 01-Apr-2014*CH*Xxxx Cosmetic Coxxx-xxxxxxx-x/x/x 01-Apr-2014*CH*Xxxx Cosmetic CoMarch 2014xxx-xxxxxxx-x/x/x 01-Mar-2014*CH*Xxxx Cosmetic CoNovember 2013xxx-xxxxxxx-x/x/x 01-Nov-2013*CH*Xxxx Cosmetic CoRefusal Details as Recorded in OASIS by FDAfor Refusal *-*-*/*/*Manufacturer FEI*Manufacturer Name* Cosmetic Co Manufacturer Address line 1*Manufacturer Address line 2Manufacturers City*Manufacturer Province/StateManufacturer Country/Area* Product Code*CH* FDA Product DescriptionEYE SHADOW Refusal Date01-Apr-2014 FDA District*-* Entry/doc/line/sfx*-*-*/*/*FDA Sample AnalysisYes FDA Record of Private Lab Sample AnalysisNo Charge(s)Violation CodeSectionCharge StatementCOLOR LBLG 602(e), 801(a)(3); MISBRANDING The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721. COSM COLOR 601(e), 801(a)(3); ADULTERATION The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section